Engineer I/II or Senior

Job Description :Foldax is developing a complete line of surgical and catheter-delivered (TAVRTMVR) synthetic heart valve products. We are looking for the ideal candidate to join our team. This position will be on a fast-paced, early product development team and the individual who fills it will play a key role in the design, development and testing of valve designs from concept to early clinical feasibility.Qualifications :You will collaborate with cross-functional teams to bring projects from concept to completion and ensure all products meet quality standards. To be successful in this position, you must possess a bachelor's degree in engineering, preferably mechanical or biomedical engineering, and have 3+ years of experience in the medical device industryYou should also have a working knowledge of design control and risk management.The ideal candidate will have an entrepreneurial spirit and be comfortable working in a fast-paced environment. If you're passionate about developing cutting-edge technologies that make a positive impact on people's lives, then this job is for you!ResponsibilitiesIn this role, you will be responsible for designing, developing and testing new transcatheter heart valve deviceImplement complex design concepts and ideas into working drawings, solid models, and prototypesPrototype design and performing feasibility assessments at a rapid paceRun empirical and experimental analysis utilizing various analytical design tools to support design improvements.Ensure all products meet quality standardsDevelop and execute test methods, procedures, work instructions and reports with minimal supervisionWrite, execute, and summarize qualification and validation reportsUse technical problem-solving techniques for solving basic equipment issuesSupervise techniciansinterns and coordinate project activitiesLargely self-directed and capable of meeting project goals with minimal supervisionAdditional Information:The primary work location for this position is Irvine, CA.This is a 100% on-site position.Less than 20% travel required.Job Type: Full-timePay: $60,000.00 - $100,000.00 per yearBenefits:401(k)Dental insuranceHealth insurancePaid time offVision insuranceWork Location: In person

Created: 2025-02-21